The effect of information provision on the blood cortisol level of patients transferring from the cardiac care unit to the general ward compared with patients who do not receive it
The purpose of this study is to determine the effect of information provision on the blood cortisol level of patients transferring from cardiac care unit to the general ward. In this experimental study, 50 patients whom hospitalized in the cardiac care unit of Tehran hospitals, will enter into two intervention and control groups. Basal cortisol level will measure before intervention. Then intervention will be started. While the patients in the control group will not receive any information about transfer to the general ward, patients in the experience group, will receive the pamphlet that contains information about transfer, continuity of care and future general ward environment. In both groups, the level of blood cortisol will be measured in 2 steps,
1: 30 min after the patient will be informed of the transferring to the general ward.
2: 30 min after the patient will be transferred to the general ward.
In the end, the blood cortisol level in intervention group will be compared with control group .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100624390N1
Registration date:2016-02-08, 1394/11/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-08, 1394/11/19
Registrant information
Name
Maryam Jamsahar
Name of organization / entity
Tehran faculty of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8497
Email address
m_jamsahar@yahoo.com
Recruitment status
Recruitment complete
Funding source
- Research project-Thesis
Expected recruitment start date
2015-10-26, 1394/08/04
Expected recruitment end date
2016-01-24, 1394/11/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of information provision on the blood cortisol level of patients transferring from the cardiac care unit to the general ward compared with patients who do not receive it
Public title
The effect of information provision on the anxiety of patients transferring from the cardiac care unit to the general ward
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. The patients' transferring to the general ward is in the morning
2. Patients should be able to understand and speak in Persian
3. Age of 18 years and older
4. Patient must be alert
5. Hospitalization for more than 24 hours in the cardiac care unit
7. Patients should not receive glucocorticoids, anticonvulsants and insulin during hospitalization.
Exclusion criteria:
1. Any intensive change in the situation of the disease during the study
2. Any type of invasive therapy during the study
3. The lack of patient consent for the continuation of cooperation in the study
4. If the patient do not need to transfer to the general ward (discharge from cardiac care unit directly)
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sixth Floor,central organization of Tehran University , Qods St., Keshavarz Blvd., Tehran
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.TUMS.REC.1394.818
Health conditions studied
1
Description of health condition studied
transfer anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified Anxiety NOS
Primary outcomes
1
Description
blood cortisol level
Timepoint
Half an hour after informing the patient of the order of transfer to the general ward and half an hour after enter the patient to the general ward
Method of measurement
RIA laboratory techniques, Dia source kit
Secondary outcomes
empty
Intervention groups
1
Description
Interventions 1: Patients in the intervention group will receive information about the general ward environment and continuity of care with a pamphlet. It contains some information about the purpose of the patient's transferring from cardiac care unit to the general ward, the geographical location of the general ward, facilities and equipment , the number of nurses per each shift, the hours of taking the laboratory samples, the hours of monitoring of vital signs, the hours of distribution of food meals, the relatives visiting hours and etc.
Category
Other
2
Description
Intervention 2: The patients in the control group will not receive any information about transfer from cardiac care unit to the general ward,continuity of care and new general ward environment in shape of pamphlet.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini educational and clinical center
Full name of responsible person
Mojdeh Navidhamidi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masood Unesian
Street address
Vice chancellor for research,Tehran University of Medical Sciences, Qods St., Keshavarz Blvd., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical sciences
Full name of responsible person
Mojdeh Navidhamidi
Position
Ph.D. of Medical Physiology
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat St., Tohid square, Tehran
City
Tehran
Postal code
-
Phone
+98 21 6105 4307
Fax
Email
m-navid@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran university of medical science
Full name of responsible person
Mojdeh Navidhamidi
Position
Ph.D. of Medical Physiology
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat St., Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4307
Fax
Email
m-navid@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Maryam Jamsahar
Position
M.Sc.
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat St., Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2509
Fax
Email
m.jamsahar8@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)